RANITYDYNA 150 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Ranitidine Aurovitas, 150 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Ranitidine Aurovitas and what is it used for
   1. What is Ranitidine Aurovitas?
   2. Indications
4. Important information before taking Ranitidine Aurovitas
   1. When not to take Ranitidine Aurovitas
   2. Warnings and precautions
   3. Ranitidine Aurovitas and other medicines
   4. Ranitidine Aurovitas with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
5. How to take Ranitidine Aurovitas
   1. Use in children and adolescents up to 18 years of age
   2. Taking a higher dose of Ranitidine Aurovitas than recommended
   3. Missing a dose of Ranitidine Aurovitas
   4. Stopping treatment with Ranitidine Aurovitas
6. Possible side effects
   1. Uncommon side effects (may affect up to 1 in 100 people):
   2. Rare side effects (may affect up to 1 in 1,000 people):
   3. Very rare side effects that may appear in blood test results:
   4. Side effects that occur very rarely (may affect up to 1 in 10,000 people):
   5. Very rare side effects that may appear in blood test results:
   6. Side effects with unknown frequency (frequency cannot be estimated from available data):
   7. Reporting side effects
7. How to store Ranitidine Aurovitas
8. Package contents and other information
   1. What Ranitidine Aurovitas contains
   2. What Ranitidine Aurovitas looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer/Importer:
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 05/2019

Leaflet attached to the packaging: patient information

Ranitidine Aurovitas, 150 mg, coated tablets

Ranitidine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ranitidine Aurovitas and what is it used for
• 2. Important information before taking Ranitidine Aurovitas
• 3. How to take Ranitidine Aurovitas
• 4. Possible side effects
• 5. How to store Ranitidine Aurovitas
• 6. Package contents and other information

1. What is Ranitidine Aurovitas and what is it used for

What is Ranitidine Aurovitas?

Ranitidine Aurovitas belongs to a group of medicines called histamine H2-receptor antagonists.
It reduces the amount of stomach acid produced, so heartburn and acid reflux no longer occur.
However, it leaves the amount of stomach acid suitable for digestion.

Indications

Ranitidine Aurovitas is used in adults and children aged 3 to 18 years for:

• Mild stomach inflammation.
• Inflammation of the intestine (duodenum) or stomach ulcers (regardless of whether they are caused by long-term use of anti-inflammatory drugs, also known as NSAIDs, commonly used to treat arthritis).
• To prevent the recurrence of stomach ulcers.
• Reflux esophagitis (esophagitis due to gastric reflux).
• Zollinger-Ellison syndrome (a disease in which the stomach produces too much acid).
• Treatment of symptoms such as heartburn and acid reflux, which can cause pain or discomfort.

If the above-mentioned disease states do not improve or worsen, you should contact your doctor.

2. Important information before taking Ranitidine Aurovitas

When not to take Ranitidine Aurovitas

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If the patient has doubts, before taking Ranitidine Aurovitas, they should consult their doctor or pharmacist.

Warnings and precautions

Before starting treatment with Ranitidine Aurovitas, the patient should discuss it with their doctor or pharmacist.

• If the patient has kidney function disorders, the doctor may reduce the dose.
• If the patient has had an acute attack of porphyria (a metabolic disease that manifests itself, among other things, with skin disorders).
• If the patient is over 50 years old.
• If the patient is on a low-sodium or sodium-free diet.
• If the patient has a history of increased risk of bleeding or is taking medications that increase the risk of bleeding (pain and anti-inflammatory medications, also known as NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
• If the patient has suddenly lost weight. Stomach cancer sometimes gives the same symptoms as those for which this medicine is indicated. These symptoms may initially decrease during treatment with this medicine. However, taking this product does not cure stomach cancer.
• If the patient has diabetes, lung disease, heart failure, or reduced immunity. The patient may have an increased risk of developing pneumonia.

Ranitidine Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect how Ranitidine Aurovitas works or may increase the risk of side effects. Ranitidine Aurovitas may also affect the way other medicines work, including:

• Procainamide or N-acetylprocainamide (a medicine used to treat heart diseases)
• Warfarin (an anticoagulant medicine)
• Medicines used to treat pain and inflammation (NSAIDs)
• Triazolam (a medicine for insomnia)
• Midazolam (a sedative medicine)
• Glipizide (a medicine that lowers blood sugar levels)
• Ketoconazole (an antifungal medicine)
• Atazanavir or delavirdine (medicines used to treat HIV infection)
• Gefitinib (a medicine for lung cancer)
• Medicines that neutralize stomach acid and sucralfate (another medicine used to treat disorders such as stomach and intestinal ulcers). Taking these medicines at the same time may reduce the absorption of ranitidine into the bloodstream (making it less effective). Therefore, these medicines should be taken about 2 hours after taking ranitidine.
• If the patient is taking erlotinib, a medicine used to treat certain types of cancer, they should talk to their doctor before taking Ranitidine Aurovitas. The ranitidine in Ranitidine Aurovitas may decrease the amount of erlotinib in the blood, which may require the doctor to adjust the dose of the medicine if it is taken during erlotinib treatment.

The patient should contact their doctor or pharmacist if they are taking any of the above medicines.

Ranitidine Aurovitas with food and drink

Ranitidine Aurovitas can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Ranitidine Aurovitas should not be taken during pregnancy and breastfeeding without prior consultation with a doctor. This is because the active substance of the medicine (ranitidine) passes through the placenta and also passes into human milk.
Before taking any medicine, the patient should discuss it with their doctor or pharmacist. The doctor will weigh the benefits and risks for the mother and child of taking Ranitidine Aurovitas.

Driving and using machines

There is no data on the effect of Ranitidine Aurovitas on the ability to drive vehicles and operate machines. In case of side effects such as disorientation, vision disturbances, hallucinations (delusions), or movement disorders, these skills may be impaired.

3. How to take Ranitidine Aurovitas

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
It is not necessary to take Ranitidine Aurovitas during meals.
The usual dose for adults is 300 mg per day, taken as:

• 1 tablet of Ranitidine Aurovitas 300 mg once a day, in the evening before bedtime.
• 1 tablet of Ranitidine Aurovitas 150 mg, twice a day, one tablet in the morning and one tablet in the evening, with approximately 12 hours between doses.
• The doctor will determine the exact dose the patient should take according to the symptoms they are experiencing.
• If the symptoms of esophagitis do not improve, the doctor may recommend taking a dose of 2 tablets of 300 mg or 4 tablets of 150 mg per day, for a maximum of eight weeks.
• In some patients (such as those with Zollinger-Ellison syndrome, associated with very high acid production), the usual dose is 3 tablets of 150 mg per day. This dose may be increased to 600-900 mg per day.
• In the treatment of stomach ulcers caused by long-term use of non-steroidal anti-inflammatory drugs, the usual dose is 1 tablet of Ranitidine Aurovitas 150 mg twice a day, for up to 12 weeks.
• If the patient has impaired kidney function, the doctor may reduce the dose of Ranitidine Aurovitas.
• Tablets should not be crushed or chewed. The tablet should be swallowed whole.

Use in children and adolescents up to 18 years of age

• For children over 12 years of age, the dose is similar to that for adults.
• This medicine is not suitable for children aged 3-11 years, as the tablet cannot be divided to adjust the dose to body weight, nor can it be crushed to facilitate swallowing. Other, suitable medicines may be available for children aged 3-11 years.

Treatment of ulcer disease
The usual dose of the medicine for children is 2 mg/kg body weight/day, given in two divided doses, for four weeks. Each dose should be taken with an interval of at least 12 hours from the previous dose.Alternatively, the dose may be increased to 4 mg/kg body weight/day, in two divided doses, taken at intervals of approximately 12 hours. The treatment may be extended to eight weeks.
Treatment of esophagitis and heartburn and/or acid reflux
The usual dose is 2.5 mg/kg body weight/day, in two divided doses, for two weeks, each dose taken at intervals of approximately 12 hours. The dose may be increased to 5 mg/kg body weight/day, in two divided doses, taken at intervals of approximately 12 hours.

Taking a higher dose of Ranitidine Aurovitas than recommended

In case of taking a higher dose of Ranitidine Aurovitas than recommended by the doctor, the patient should immediately contact their doctor or pharmacist. If possible, the patient should show the packaging of the medicine. In case of overdose of Ranitidine Aurovitas, side effects may occur, listed in section 4 "Possible side effects". Additionally, in adult patients, overdose may cause drowsiness and nausea. In children, overdose may cause vomiting, irritability, and insomnia.

Missing a dose of Ranitidine Aurovitas

In case of missing a dose, the patient should take the missed dose as soon as possible. However, if it is close to the time of taking the next dose, the patient should skip the missed dose and continue with the normal dosing schedule. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Ranitidine Aurovitas

It is important to continue taking Ranitidine Aurovitas until the doctor determines that the treatment can be stopped, even if the patient feels better. If the patient does not complete the treatment as directed by the doctor, the treatment may be ineffective, and the symptoms may return.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ranitidine Aurovitas can cause side effects, although not everybody gets them.
Side effects in children may be similar to those in adults.
Allergic reactions:Rarely occur in patients taking Ranitidine Aurovitas. Symptoms may include:

• Rash with intense itching and hives
• Swelling of the face and mouth (angioedema)
• Chest pain, shortness of breath, unexplained fever, wheezing, or difficulty breathing
• Feeling of fainting, especially when standing up
• Fainting

If any of the above symptoms occur, the patient should immediately inform their doctor or pharmacist and stop taking Ranitidine Aurovitas.
Severe skin reactions:Very rarely occur in patients taking Ranitidine Aurovitas. Symptoms include:

• Skin rash that can cause blisters and may look like small spots (central dark spots surrounded by a lighter area, with a dark ring around the edge). If any of these symptoms occur, the patient should immediately inform their doctor or pharmacist and stop taking Ranitidine Aurovitas.

Uncommon side effects (may affect up to 1 in 100 people):

• Abdominal pain
• Constipation
• Nausea (vomiting)

Rare side effects (may affect up to 1 in 1,000 people):

• Allergic reactions
• Rash

Very rare side effects that may appear in blood test results:

• Changes in liver function tests
• Increased creatinine levels in blood serum (related to kidney function tests)

Side effects that occur very rarely (may affect up to 1 in 10,000 people):

• Feeling of confusion or depression or seeing or hearing things that are not there (hallucinations)
• Headache, dizziness
• Uncontrolled movements
• Blurred vision
• Slow or irregular heartbeat (bradycardia)
• A type of conduction disorder in the heart, leading to arrhythmias (atrioventricular block)
• Increased heart rate (tachycardia)
• Vasculitis
• Pancreatitis
• Diarrhea
• Hepatitis, sometimes with yellowing of the whites of the eyes or yellowing of the skin (jaundice)
• Rash with irregular red spots (erythema multiforme)
• Unexpected hair loss or thinning (alopecia)
• Joint or muscle pain
• Kidney inflammation (interstitial nephritis)
• Impotence
• Galactorrhea
• Breast tenderness and/or breast enlargement in men (gynecomastia)

Very rare side effects that may appear in blood test results:

• Low white blood cell count (leukopenia)
• Decreased platelet count (thrombocytopenia)
• Decrease in the number of certain types of blood cells

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Shortness of breath

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Ranitidine Aurovitas

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Ranitidine Aurovitas contains

• The active substance of the medicine is ranitidine. Each coated tablet contains 150 mg of ranitidine (as hydrochloride).
• The other ingredients of the medicine are: Core of the tablet:microcrystalline cellulose (E 460), sodium croscarmellose (E 468), magnesium stearate (E 470b). Coating of the tablet: hypromellose (5 cp), titanium dioxide (E 171), triacetin.

What Ranitidine Aurovitas looks like and what the package contains

Coated tablet.
White to almost white, round, coated tablets, with the inscription 'K' on one side and '150' on the other.
Ranitidine Aurovitas coated tablets are available in PA/Al/PVC/Al blisters.
Package sizes:10, 20, 28, 30, or 60 coated tablets.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

Manufacturer/Importer:

Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip HA4 6QD.
United Kingdom
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Ranitidine Aurovitas
Italy:
Ranitidina Aurobindo Italia
Netherlands
Ranitidine Aurobindo 150 mg/ 300 mg, film-coated tablets
Poland:
Ranitydyna Aurovitas
Spain
Ranitidina Aurovitas 150 mg/ 300 mg coated tablets EFG

Date of last revision of the leaflet: 05/2019